Cleared Special

K111060 - MRGFUS PELVIC PA COIL MODEL 1.0

K111060 is an FDA 510(k) clearance for MRGFUS PELVIC PA COIL MODEL 1.0, manufactured by Insightech, Ltd.. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 144-day FDA review.

K111060 · Insightech, Ltd. · Radiology device
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Sep 2011
Decision
144d
Days
Class 2
Risk

K111060 is an FDA 510(k) clearance for the MRGFUS PELVIC PA COIL MODEL 1.0. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Insightech, Ltd. (Tirat Carmel, IL). The FDA issued a Cleared decision on September 9, 2011 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Insightech, Ltd. devices

FDA 510(k) Submission Details - K111060

510(k) Number K111060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2011
Decision Date September 09, 2011
Days to Decision 144 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 107d · This submission: 144d
Pathway characteristics
Modification to existing cleared device.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 338
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